Evaluation of Pharmacogenomics Testing to Precision Prescriptions in Periodontal Patients

The different patients responses to medications vary from dose effectiveness to adverse drug reaction (ADRs). ADRs affect outpatient settings as it account for estimated 1 million emergency department visits and over 3.5 million physician office visits per year. This subsequently results in about 125,000 hospital admissions. Currently, genetic testing conclude recommendation of dose adjustment or drug stop. However, further step is needed toward individually tailored prescription plan. The purpose of this study is to determine if the efficacy of the genetic testing (Pharmacogenomics) combined with the dietary habits and medications history to design an individually tailored prescription plan. This individualized-prescriptions will be tested if to reduce adverse drug reaction and improve pain management in periodontal surgeries. Hence, the current study will recruit subjects planned for two periodontal surgeries and evaluate pain management during and after periodontal surgery as well as post-surgical complication with and without individually tailored prescription plan. In addition, a comparison will be performed on number of drugs added, stopped or had a dose adjustment.

Study Overview

• Status: Enrolling by invitation
• Conditions: Oral Surgeries
• Intervention / Treatment: Drug: Local anesthetics, IV sedation drugs and analgesics.

Detailed Description

The objective of this study is to combine pharmacogenomics testing with social, dietary and medications history to formulate individualized-prescription plan and to test the effectiveness of this precession approach to reduce adverse drug reaction and improve pain management during and after periodontal surgeries.

The specific aims of the study are:

• Specific aim 1: To test the efficacy of combining pharmacogenomics, dietary habits as well as social and medical history data to tailor a personalized prescription for each periodontal patient.
• Specific aim 2: To determine the ability of personalized prescription to achieve more efficacious pain management during and after periodontal surgery. The study also aims to determine the effect of this approach in the adjustment of opioid dosages for these patients.
• Specific aim 3: To determine the effect of personalized prescription, using pharmacogenomics tool, on post-surgical complications related to medications.

Self-controlled case series (SCCS) design will be used for the study. After eligibility has been ascertained and consent has been obtained, subjects planned for 2 surgeries will be enrolled in the study. First surgery will be carried out with the standard prescription for medications. For the second surgery, medications will be prescribed based on individualized assessment and pharmacogenomics report for each subject. These medications will be prescribed based on a consult with the periodontal surgeon's and PhamD investigators of the study. Medications that will be assessed in the study are: local anesthetics, IV sedation drugs and analgesics.

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University-Dental College of Georgia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects at least 18 years of age
• All potential subjects must sign an informed consent prior to study enrollment
• Subjects willing to receive a standard full-mouth periodontal examination
• Subjects planned for 2 or more periodontal surgeries.

Exclusion Criteria:

• Subjects with medical conditions that contraindicate periodontal surgeries. These medical condition include: recent myocardial infarction and cerebrovascular accident, recent valve prosthesis surgery, immunosuppression, uncontrolled bleeding disorders, active treatment of malignancy as well as intravenous bisphosphonate use.
• Subjects with back and neck injuries that will not allow them to be in supine position.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Subject will receive standard prescription for local anesthetics, IV sedation drugs and analgesics at the time of first surgery. Subject will receive individually tailored-prescription for local anesthetics, IV sedation drugs and analgesics, based upon pharmacogenomic assessment at the time of second surgery.	Drug: Local anesthetics, IV sedation drugs and analgesics.; Personalized prescription for local anesthetics, IV sedation drugs and analgesics, based on pharmacogenomic assesment, social, dietary and medication history

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in subject-reported post-surgery pain levels	Patient 's assessment of the pain on a scale of 0-10 in the first week after the surgery	Average of pain ratings, recorded after each surgery in the first week after the surgery. Patient will receive 1 call every 2 days to report his/her pain scale. Patient will receive a total of 3 calls in the 1st week after surgery.
Changes in post-surgery complications related to medications	Post-operative complication will be classified for 6 grades.	Post-operative complication will be assessed 2-4 weeks after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in post-surgery sedation assessment	Evaluated using Riker Sedation-Agitation Scale	Evaluated by the surgeon at the same day of the surgery where sedation performed

Collaborators and Investigators

• Sponsor: Augusta University
• Investigators: Principal Investigator: Ahmed El-Awady, BDS, MS, PhD, Dental College of Georgia-Augusta University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Pharmacogenomics; Precision prescriptions
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Analgesics
• Other Study ID Numbers: 1490009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No